What is considered medical grade foam?

Searching the Internet for a foam deemed “medical grade” can be an intimidating and discouraging mission. This is especially true when the search results yield an overwhelming amount of similar buzz words to decipher and distinguish (i.e. medical foam, medical grade foam, foam used in medical products, etc.). The term “medical grade” foam means many things to many different people. Here at UFP Technologies, we follow a simple set of guidelines and definitions which allow us to determine the most functional and economical foam to use in our customers’ medical applications. Below are the most
common foam definitions we use to help select the correct material for your project:

Biocompatibility
The foam has been tested, passed and certified to comply with the ISO 10993 protocol.

Fixed Formulation
The raw material formulation may be registered with the FDA. Should the material change, it is determined that the foam is not able to be categorized as a medical grade foam without additional testing.

FDA Master File
This is where foam formulations are registered with the FDA. It is important to remember that a foam with an FDA master file means that the formulation is registered with the FDA. It does not necessarily mean that the foam is “medical grade.” Additional biocompatibility testing will determine whether or not the foam is appropriate for use in medical applications.

510K Submissions
We will work with the raw material supplier and customer to determine if the foam has previously been registered in a 510K application.

USP Classification
This is a raw material registration used primarily in the pharmaceutical industry.

UFP Technologies’ sales and engineering teams pair your project’s requirements with the above classifications to ensure that we are providing you with a superior, technical foam solution. We are then equipped to engineer and fabricate an innovative solution for you at one of our ISO 13485:2003 manufacturing sites. The ISO 13485:2003 certification is a method of systems and documentation to ensure that the manufacturer does not change the raw material or the methods of fabricating during the manufacturing process. Choosing to keep the production within an ISO 13485:2003 facility is becoming an industry standard. After all, the investment of time and economics has already been made to determine the appropriate medical grade foam.

I am designing a medical device packaging tray for a set of dental implant tools.
Do you have access to “Medical Device Grade” closed cell foam materials that would be suitable for precision die cutting. These foam sheets would hold the dental implant tools inside the vacuum formed tray and would be gamma sterilized in this sealed packaging tray.